# K063381: CT Compatible F/S/D Applicators

- Pathway: 510(k) (Traditional)
- Applicant: Mick Radio-Nuclear Instruments, Inc.
- Decided: Dec 22, 2006 after 44 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K864210 (1986). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955844: Applicators for Varian Varisource Remote High Dose Rate Afterloader, Varian Assoc., Inc. (1996) Summary page 1.
- K913908: Omnitron Gyn Applicator System, Omnitron Intl., Inc. (1992) Summary page 1.
- K030110: CT HDR Tandem/Ring Applicator with Rectal Retractor, Mick Radio-Nuclear Instruments, Inc. (2003) Summary page 1.
- K040704: Modification to Henschke HDR Cervix Applicator and Hilaris/Nori HDR Cervix Applicator, Mick Radio-Nuclear Instruments, Inc. (2004) Summary page 2.

## Most influential descendants
- K200221: CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor (2020), 0 descendants of its own

## Indications for use
The CT Compatible F/S/D applicator is indicated for use in any case where high dose rate (HDR) radiation treatment of cancer in the cervix and uterus is an accepted clinical practice.

Source page: https://510kreport.com/device/K063381
Methodology: https://510kreport.com/methodology